Barriers and facilitators to representative acute leukemia trial participation at National Cancer...

Demographic enrollment disparities in adult acute leukemia clinical trials limit generalizability and diminish opportunities for minoritized populations to benefit from novel therapies. The distinct natural history and clinical research landscape of acute leukemia, the latter of which is centralized at the National Cancer Institute-designated Comprehensive Cancer Centers (CCCs), pose challenges to eliminating this disparity.

We performed an analysis of 2 qualitative focus group and interview-based studies to characterize barriers and facilitators to representative acute leukemia clinical trial participation. Participants were patients with acute leukemia belonging to under-enrolled demographic groups (female, older adults, Hispanic ethnicity, or non-White race) and clinicians who treat and enroll them in clinical trials at CCCs in Massachusetts and Ohio.

Eight focus groups and 7 individual interviews were performed with 61 participants (34 patients and 27 clinicians). Barriers idiosyncratic to acute leukemia included inpatient and resource-intensive outpatient care, limited time between diagnosis and treatment initiation, low disease prevalence leading to trial centralization, and barriers related to hematopoietic stem cell transplantation. Barriers common across cancer types included restrictive eligibility criteria, complex study logistics, and cost. Potential solutions included local hospital and CCC partnerships and navigation to enhance timely referral and co-management during participation, multi-modal trial education and peer support in the peri-diagnostic period, minimizing unnecessary eligibility criteria, and travel and financial assistance.

Patients and clinicians identified actionable steps to improve trial participation that address the unique challenges for adults with acute leukemia. A multi-pronged and disease-specific approach is needed to achieve representative acute leukemia clinical trials.